12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension

April 14, 2020 updated by: Axovant Sciences Ltd.

A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease

This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1099

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1828CKR
        • AR101
      • Buenos Aires, Argentina, C1199ABB
        • AR060
      • Ciudad Autonoma de Buenos Aire, Argentina, C1012AAR
        • AR084
      • Ciudad Autonoma de Buenos Aire, Argentina, C1058AAJ
        • AR027
      • Ciudad Autonoma de Buenos Aire, Argentina, C1111AAL
        • AR012
      • Ciudad Autonoma de Buenos Aire, Argentina, C1117ABH
        • AR160
      • Ciudad Autonoma de Buenos Aire, Argentina, C1406BOA
        • AR028
      • Ciudad Autonoma de Buenos Aire, Argentina, C1428AQK
        • AR035
      • Ciudad Autónoma de Buenos Aire, Argentina, C1405BCK
        • AR040
      • Ciudad Autónoma de Buenos Aire, Argentina, C1425AHQ
        • AR081
      • Córdoba, Argentina, X5000DCE
        • AR051
      • Córdoba, Argentina, X5000FJF
        • AR137
      • Córdoba, Argentina, X5004AOA
        • AR126
      • Mendoza, Argentina, M5501ACP
        • AR210
      • Mendoza, Argentina, M5502AHV
        • AR219
      • Santiago del Estero, Argentina, G4200DND
        • AR059
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, A1902AJU
        • AR130
  • Australia
      • Caulfield, Australia, VIC 3162
        • AU227
      • Heidelberg West, Australia, VIC 3081
        • AU032
      • Hornsby, Australia, NSW 2077
        • AU011
      • West Perth, Australia, WA 6005
        • AU138
  • Bulgaria
      • Ruse, Bulgaria, 7003
        • BU125
      • Sofia, Bulgaria, 1431
        • BU131
      • Varna, Bulgaria, 9000
        • BU073
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • CA054
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • CA188
      • Penticton, British Columbia, Canada, V2A 5C8
        • CA186
      • West Vancouver, British Columbia, Canada, V7T 2Z3
        • CA141
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 5G8
        • CA147
      • North York, Ontario, Canada, M3B 2S7
        • CA196
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8JI
        • CA236
  • Chile
    • II Región
      • Antofagasta, II Región, Chile, 1270244
        • CH212
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 7560356
        • CH076
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7510186
        • CH061
      • Santiago, Región Metropolitana, Chile, 7520338
        • CH075
  • Croatia
      • Zagreb, Croatia, 10000
        • CR069
      • Zagreb, Croatia, 10000
        • CR122
      • Zagreb, Croatia, 10090
        • CR070
  • Czechia
      • Praha, Czechia, 100 00
        • CZE207
      • Praha 10, Czechia, 100 00
        • CZE128
      • Praha 2, Czechia, 12000
        • CZE132
      • Praha 6, Czechia, 160 00
        • CZE129
      • Rychnov nad Kneznou, Czechia, 516 01
        • CZE161
  • France
      • Lille Cedex, France, 59037
        • FR231
      • Marseille Cedex 5, France, 13385
        • FR182
      • Paris Cedex, France, 75013
        • FR221
      • Villeurbanne, France, 69 100
        • FR202
  • Germany
      • Bad Homburg, Germany, 61348
        • GE206
      • Berlin, Germany, 10117
        • GE091
      • Berlin, Germany, 12203
        • GE071
      • Berlin, Germany, 13125
        • GE139
      • Cologne, Germany, 50937
        • GE230
      • Ellwangen, Germany, 73479
        • GE252
      • Leipzig, Germany, 04107
        • GE180
      • Mannheim, Germany, 68165
        • GE228
      • Munchen, Germany, 81675
        • GE017
      • Nürnberg, Germany, 90402
        • GE157
      • Ulm, Germany, 89081
        • GE098
      • Westerstede, Germany, 26655
        • GE251
  • Italy
      • Brescia, Italy, 25125
        • IT053
      • Cefalu, Italy, 90015
        • IT124
      • Pavia, Italy, 27100
        • IT030
      • Perugia, Italy, 06156
        • IT103
      • Roma, Italy, 00168
        • IT072
      • Roma, Italy, 00189
        • IT029
      • Rome, Italy, 00179
        • IT183
      • Rome, Italy, 00185
        • IT175
      • Torino, Italy, 10 126
        • IT085
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • SK066
      • Seoul, Korea, Republic of, 06351
        • SK067
      • Seoul, Korea, Republic of, 07061
        • SK190
  • Poland
      • Bialystok, Poland, 15-756
        • PO013
      • Bydgoszcz, Poland, 85-080
        • PO024
      • Bydgoszcz, Poland, 85-796
        • PO010
      • Katowice, Poland, 40-123
        • PO107
      • Katowice, Poland, 40-749
        • PO092
      • Poznan, Poland, 61-853
        • PO009
      • Szczecin, Poland, 70-111
        • PO014
      • Warszawa, Poland, 01-697
        • PO074
  • Serbia
      • Belgrade, Serbia, 11 000
        • SE164
      • Belgrade, Serbia, 11 000
        • SE193
      • Belgrade, Serbia, 11000
        • SE090
      • Kragujevac, Serbia, 34 000
        • SE155
      • Novi Kneževac, Serbia, 23330
        • SE031
      • Vršac, Serbia, 26300
        • SE165
  • Singapore
      • Singapore, Singapore, 119074
        • SI052
      • Singapore, Singapore, 308433
        • SI026
  • Slovakia
      • Banska Bystrica, Slovakia, 974 04
        • SL056
      • Dubnica nad Vahom, Slovakia, 018 41
        • SL200
      • Krompachy, Slovakia, 040 01
        • SL078
      • Krompachy, Slovakia, 05342
        • SL078
      • Svidník, Slovakia, 08901
        • SL077
  • Spain
      • Alicante, Spain, 03690
        • SP249
      • Barcelona, Spain, 08003
        • SP176
      • Barcelona, Spain, 08028
        • SP022
      • Barcelona, Spain, 08035
        • SP021
      • Barcelona, Spain, 08036
        • SP250
      • Barcelona, Spain, 08195
        • SP184
      • Getxo, Spain, 48993
        • SP222
      • San Sebastián, Spain, 20014
        • SP194
  • Taiwan
      • Taoyuan, Taiwan, 333
        • TA121
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • UK063
      • Blackpool, United Kingdom, FY2 0JH
        • UK038
      • Cambridge, United Kingdom, CB21 5EF
        • UK233
      • Carnoch, United Kingdom, WS11 0BN
        • UK033
      • Epping, United Kingdom, CM16 6TN
        • UK211
      • Guildford, United Kingdom, GU2 7YD
        • UK234
      • Leeds, United Kingdom, LS10 1DU
        • UK055
      • London, United Kingdom, W1G 9RU
        • UK039
      • Manchester, United Kingdom, M13 9NQ
        • UK034
      • Oxford, United Kingdom, OX3 9DU
        • UK087
      • Plymouth, United Kingdom, PL5 8BT
        • UK235
      • Sheffield, United Kingdom, S5 7JT
        • UK100
      • Southampton, United Kingdom, SO16 6YD
        • UK064
      • Southampton, United Kingdom, SO30 3JB
        • UK152
      • Swindon, United Kingdom, SN3 6BW
        • UK153
      • Warrington, United Kingdom, WA22 8WA
        • UK154
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85005
        • US112
      • Tucson, Arizona, United States, 85704
        • US220
    • California
      • Rancho Mirage, California, United States, 92270
        • US096
      • Santa Ana, California, United States, 92705
        • US195
      • Simi Valley, California, United States, 93065
        • US016
      • Temecula, California, United States, 92591
        • US106
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • US179
      • Norwich, Connecticut, United States, 06360
        • US171
    • Florida
      • Atlantis, Florida, United States, 33462
        • US088
      • Brooksville, Florida, United States, 34601
        • US007
      • Hallandale Beach, Florida, United States, 33009
        • US002
      • Hialeah, Florida, United States, 33012
        • US140
      • Miami, Florida, United States, 33137
        • US216
      • Miami, Florida, United States, 33165
        • US110
      • North Palm Beach, Florida, United States, 33408
        • US172
      • Orlando, Florida, United States, 32806
        • US003
      • Pensacola, Florida, United States, 32502
        • US256
      • Tampa, Florida, United States, 33613
        • US037
      • Tampa, Florida, United States, 33613
        • US042
      • The Villages, Florida, United States, 32162
        • US004
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • US048
      • Atlanta, Georgia, United States, 30342
        • US046
      • Columbus, Georgia, United States, 31909
        • US217
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • US111
      • Shreveport, Louisiana, United States, 71104
        • US095
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • US116
      • Quincy, Massachusetts, United States, 02169
        • US174
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • US144
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • US094
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • US135
      • Lawrenceville, New Jersey, United States, 08648
        • US197
      • Manchester, New Jersey, United States, 08759
        • US057
      • Mount Arlington, New Jersey, United States, 07856
        • US215
      • Toms River, New Jersey, United States, 08755
        • US209
      • West Long Branch, New Jersey, United States, 07764
        • US036
    • New York
      • Albany, New York, United States, 12208
        • US001
      • Brooklyn, New York, United States, 11235
        • US049
      • New Hyde Park, New York, United States, 11040
        • US097
      • New York, New York, United States, 10022
        • US044
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • US150
      • Charlotte, North Carolina, United States, 28270
        • US185
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • US008
      • Cleveland, Ohio, United States, 44106
        • US113
      • Shaker Heights, Ohio, United States, 44122
        • US119
    • Oregon
      • Portland, Oregon, United States, 97210
        • US134
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • US169
      • Plains, Pennsylvania, United States, 18075
        • US162
      • Willow Grove, Pennsylvania, United States, 19001
        • US148
    • Texas
      • San Antonio, Texas, United States, 78229
        • US043
    • Utah
      • Orem, Utah, United States, 84058
        • US143
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • US149
    • Washington
      • Spokane, Washington, United States, 99202
        • US170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completed last on-treatment visit of the lead-in study RVT-101-3001

Exclusion Criteria:

  • Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RVT-101 35 mg tablets
once daily, oral tablets
Drug: RVT-101 35 mg tablets
once daily, oral tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
Time Frame: Baseline to 12 months or Early Termination
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Baseline to 12 months or Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axovant Sciences Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ilise Lombardo, MD, Axovant Sciences, Inc., Vice President, Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RVT-101-3002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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